Clinical Trials Data Coordinator

The Department Of Medical Research

This position is responsible for the collection, processing, and quality control of clinical trial data. May assist with screening patients for eligibility to selected protocols. Maintains research protocol information, regulatory documentation, or other research files as applicable. Follows federal and local regulatory requirements, departmental, Institutional Review Board, Good Clinical Practice.

Responsible for extracting data from source documentation and entering the case report forms in a timely manner according to sponsor requirements and Standard Operating Procedures (SOP); follows applicable regulatory requirements and principles of ICH E6 Good Clinical Practice Guidelines (GCP). Responsible for resolving all data queries in a timely manner according to sponsor requirements and SOP's.

Organize and maintain recruitment files and subject files, including research shadow charts for each subject. Coordinate coding and entering of research data into applicable and appropriate data base. Check data for accuracy. Assist in the maintenance of the clinical data base, including chart retrieval and review.

Responsible for coordinating the collection and for processing and submitting to appropriate entities all requested laboratory specimens (blood and other tissue, including coordinating tumor tissue preparation requirements with Pathology) according to protocol and sponsor requirements.

Responsible for processing and submitting required imaging data to appropriate entities according to protocol and sponsor requirements.

Responsible for coordinating, scheduling, preparing, and hosting all monitoring and auditing activities.

Responsible for processing, filing, and maintaining applicable regulatory
documentation. May assist with screening of patients for potential eligibility to selected clinical trials; may assist with enrollment and/or randomization of research participants. May assist with subject scheduling of procedures required to maintain protocol compliance.

Additional responsibilities include but are not limited to IND Safety Report/SUSAR management and participation in quality improvement initiatives.

May assist with investigational drug accountability activities for applicable studies where IDS not utilized.

Shift Type: Monday - Friday, 8:00 a.m. to 5:00 p.m.

Bachelor's degree or an equivalent combination of education and relevant experience and at least 1 year of experience from which comparable knowledge and skills can be acquired is necessary.

1-2 years clinical research data coordination experience strongly preferred (required level II). Research certification (Association of Clinical Research Professionals, Society of Clinical Research Associates).

Hiring Range: $18.50 - $27.87
Grade: GGS-008
University Title: RESEARCH SPECIALIST II
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

In addition to filling out the online application please provide a resume.

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen cultural festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits.

Values Commitment

We value the uniqueness of every individual and strive to ensure each person's success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement. This commitment makes our university a better place to work, learn and innovate.

In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research, and engagement.

Equal Employment Opportunity

The University of Missouri System is an Equal Opportunity Employer. Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, or protected veteran status, or any other status protected by applicable state or federal law. This policy applies to all employment decisions including, but not limited to, recruiting, hiring, training, promotions, pay practices, benefits, disciplinary actions and terminations. For more information, visit https://www.umsystem.edu/ums/hr/eeo or call the Director of Employee and Labor Relations at 573-882-2146.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.